Bioengineer with expertise in viral vector process development, process validation, manufacturing, and analytics
CMC
品質とコンプライアンス
薬事
ビジネスアナリティクス
Jacob joined Dark Horse Consulting in January of 2021, bringing expertise and training in Viral Vectors, Biochemical Engineering, and Molecular Biology. Jacob’s prior work in industry focused on process and analytical development of gene therapy viral vectors, spanning from pre-clinical development through clinical manufacturing and process validation for over 7 clinical-stage programs.
Jacob held increasing roles at Adverum Biotechnologies in Process Development, focusing primarily on Upstream and Downstream development of an SF9-Baculovirus AAV process. While in these roles, Jacob also developed several novel methods for advanced AAV analytics using Next-generation Sequencing which led to the invention of a patent-pending analytical method.
While at Orchard Therapeutics, Jacob focused on the Process Validation and Process Characterization of late-phase Lentiviral Vectors (LVV) for Orchard’s rare disease portfolio. He oversaw the Process Characterization and PPQ strategy of a late-phase program using a Quality-by-Design approach, resulting in an effective PPQ strategy. Jacob authored and oversaw multiple Process Characterization protocols, reports, and assessments to develop a Process Control Strategy. In addition to these responsibilities, Jacob supported external LVV manufacturing activities including root cause analyses and serving as person-in-plant for multiple manufacturing batches.
During his time at CODA Biotherapeutics, Jacob led the Process Development team focused on the scale-up and development of a suspension AAV process and developed partnerships with CDMOs for AAV manufacturing.
Jacob holds a Six Sigma Green Belt certification, and has completed certificates from ISPE in Process Validation, and ASQ in Design of Experiments.
Jacob co-authored a DHC-published white paper titled “Beyond Empty and Full: Understanding Heterogeneity in rAAV Products and Impurities,” detailing the importance of product characterization and heterogeneity in product-related impurities to improve product understanding and inform manufacturing strategy.
Jacob also co-authored the first externally-prepared proposed draft FDA guidance, on the topic of “Proposed DRAFT guidance for FDA Consideration: Testing of Adeno-Associated Viral (AAV) Vector-Based Human Gene Therapy Products for Empty Capsids During Product Manufacture.” The proposed draft guidance, which can be found in its entirety here, aims to offer a benchmarking goal in making a recommendation to establish a release criterion for empty AAV vector capsid impurity. The guidance was formally submitted to the FDA on May 15, 2022.
Jacob co-led a gene therapy seminar at The Bioprocessing Summit in both 2022 and 2023.
Dark Horse Consulting Group
Senior Consultant
Consultant
CODA Biotherapeutics
Senior Process Development Engineer
Orchard Therapeutics
Senior Engineer, Process Validation
Adverum Biotechnologies
Engineer II, Process Development
Oregon State University
B.S. in Bioengineering (cum laude) with minors in Mathematics and Bioenergy
